| CTRI Number |
CTRI/2024/10/075231 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial for Evaluating the Effectiveness of a New Nano Formulation vs. Standard conventional formulation of Ursodeoxycholic Acid for Treating Liver Disease. |
|
Scientific Title of Study
|
A prospective, randomized, assessor blinded, two arm, comparative, Phase IV, single center, investigator initiated clinical study to assess the impact of nano formulation of ursodeoxycholic acid as compared to conventional formulation of ursodeoxycholic acid on liver markers in patients with liver diseases. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IIS/PS/24/01 Version 00 Dated 04 Sep 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Head – Medical Services |
| Affiliation |
Clinexcel Research |
| Address |
297 / 301, 2nd floor, Clinical research room, SoBo Centre, South
Bopal,
Ahmadabad
GUJARAT
380058
India |
| Phone |
7600012192 |
| Fax |
|
| Email |
drjayesh@clinexcelresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Head – Medical Services |
| Affiliation |
Clinexcel Research |
| Address |
297 / 301, 2nd floor, Clinical research room, SoBo Centre, South
Bopal,
GUJARAT
380058
India |
| Phone |
7600012192 |
| Fax |
|
| Email |
drjayesh@clinexcelresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Head – Medical Services |
| Affiliation |
Clinexcel Research |
| Address |
297 / 301, 2nd floor, Clinical research room, SoBo Centre, South
Bopal,
GUJARAT
380058
India |
| Phone |
7600012192 |
| Fax |
|
| Email |
drjayesh@clinexcelresearch.com |
|
|
Source of Monetary or Material Support
|
| Investigator Initiated Study (Room No. 08, Burns Ward, 02nd Floor, V.s.. Hospital, Paldi, 380006, Gujarat, India :Dr. Parth Shah) |
|
|
Primary Sponsor
|
| Name |
Dr Parth Shah |
| Address |
Room No. 08, Burns Ward, 02nd Floor, Paldi, V.S.. Hospital, Paldi, Ahmedabad. 380006, Gujarat, India. |
| Type of Sponsor |
Other [[ Self (Principal Investigator) ]] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parth Shah |
Seth Vadilal Sarabhai General Hospital |
Room No. 08, Burns Ward, 02nd Floor, Seth Vadilal Sarabhai General Hospital , Paldi
Ahmadabad
GUJARAT |
9924939099
doctorparthshah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aatman Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K768||Other specified diseases of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ulyses 300 tablets |
One tablet twice daily for 28 days |
| Comparator Agent |
ursodeoxycholic acid 300 (Generic) tablets |
One tablet twice daily for 28 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either gender between 18-65 years of age (both inclusive)
2. Patients with established diagnosis of NAFLD, drug induced hepatitis, acute viral hepatitis, alcoholic hepatitis
3. Patients with elevated liver enzymes (at least 2 times upper limit of normal) requiring treatment with UDCA
4. Patients willing to provide written informed consent and comply with the protocol requirements
|
|
| ExclusionCriteria |
| Details |
1.Patients who have used UDCA in last three months
2.Patients with recurrent variceal bleeding, spontaneous portosystemic encephalopathy, diuretic-resistant ascites, bacterial peritonitis or anticipated need for transplantation within 1 year
3.Patients using any other prescribed or over the counter medication affecting liver function at screening
4.Patients with known hypersensitivity to the study drug
5.Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
6.Participation in another clinical trial within 3 months prior to screening
7.Patients with renal dysfunction (creatinine more than 1.5 of ULN) at screening
8.Patients with any other clinically significant cardiac, endocrine, pulmonary, gastrointestinal or neurological disorder
9.Participation in another clinical trial within 3 months prior to screening
10.Any other reason for which the investigator feels that the patient should not participate
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage change in AST levels |
Baseline(Day 0) Vs Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage change in ALT, ALP, GGT and bilirubin levels |
Baseline(Day 0) Vs Day 7,14,21,28 |
| Percentage change in AST level |
Baseline(Day 0) Vs Day 7,14,21 |
| Proportion of patients achieving normal AST, ALT GGT and bilirubin levels |
at 7 days, 14 days, 21 days and 28 days |
| Adverse events reported during the study |
Basline (Day 0) to End of study |
| Serious adverse events reported during the study |
Basline (Day 0) to End of study |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study, patients with established diagnosis of liver diseases
including NAFLD, drug induced hepatitis, acute viral hepatitis, Alcoholic
hepatitis with elevated liver enzymes (at least 2 times upper limit of normal)
requiring treatment with UDCA will be screened and
enrolled if found eligible (visit 1). All the eligible patients will be
followed up on an outpatient basis with scheduled visits at end
of day 14 ± 2
days (visit 2) and day 28 ± 2 days (visit 3).
This will be a two-arm study and all the enrolled patients will be instructed
to take the study medication for a treatment period of 28 days. |